FDA product code HIF: Insufflator, Laparoscopic
HIF is the FDA product code for insufflator, laparoscopic. It is a Class II device, regulated under 21 CFR 884.1730 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 179 510(k) submissions under HIF, 18 in the last five years, from 102 different applicants. The average 510(k) review took 192 days (median 144); 196 days on average over the last three years. FDA has posted 29 recalls for HIF devices, 17 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Insufflator, Laparoscopic |
| Device class | Class II |
| Regulation | 21 CFR 884.1730 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for HIF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 177 |
| 2018 | 3 | 187 |
| 2019 | 2 | 50 |
| 2020 | 4 | 93 |
| 2021 | 1 | 128 |
| 2022 | 1 | 175 |
| 2023 | 7 | 176 |
| 2024 | 4 | 162 |
| 2025 | 3 | 164 |
| 2026 | 3 | 262 |
Compare with all 510(k) review times · Search every HIF clearance
Top HIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Northgate Technologies, Inc. | 16 | 2012-08-17 |
| Lexion Medical, LLC | 12 | 2019-08-28 |
| KARL STORZ Endoscopy-America, Inc. | 9 | 2017-03-02 |
| W.O.M. World of Medicine GmbH | 7 | 2020-07-29 |
| Richard Wolf Medical Instruments Corp. | 7 | 2001-08-27 |
97 more applicants have HIF clearances. See the full list in Caduvo.
Most recent HIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260209 | Karl Storz SE & CO. KG | ENDOFLATOR+; Smart Smoke Evacuation | 2026-08-19 | 208 |
| K252584 | Weyo Surgical Technology , Ltd. | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | 2026-06-25 | 314 |
| K252318 | Guangdong Optomedic Technologies, Inc. | Insufflator (OPTO-IFL1000) | 2026-04-16 | 265 |
| K250388 | Karl Storz SE & CO. KG | ENDOFLATOR + | 2025-09-22 | 223 |
| K242772 | SmartsurgN, Inc. | AirSurgN Insufflator (10030/AirSurgN) | 2025-04-11 | 210 |
Recalls for HIF devices
29 product recalls in 15 recall events; 17 initiated in the last five years and 17 still open. Most recent: 2026-06-16.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 2 |
| 2026 | 15 |
Frequently asked questions
What is FDA product code HIF?
HIF is the FDA product code for insufflator, laparoscopic. It is a Class II device, regulated under 21 CFR 884.1730 and reviewed by the Obstetrics and Gynecology panel.
What device class is HIF?
Class II, regulation 21 CFR 884.1730. Typical premarket route: 510(k).
How long does a 510(k) take for product code HIF?
Across 179 cleared submissions the average was 192 days from receipt to decision (median 144).
Which companies have the most HIF clearances?
Northgate Technologies, Inc. (16); Lexion Medical, LLC (12); KARL STORZ Endoscopy-America, Inc. (9); W.O.M. World of Medicine GmbH (7); Richard Wolf Medical Instruments Corp. (7).
Have HIF devices been recalled?
Yes: 29 product recalls across 15 recall events; the most recent began 2026-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HIF
- Run a recall and safety report across every HIF manufacturer
- Watch product code HIF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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